This is Steven Salzberg's blog on genomics, pseudoscience, medical breakthroughs, higher education, and other topics, including skepticism about unscientific medical practices. Here's where I can say what I really think about abuses and distortions of science, wherever I see them.

Universities should support open access to literature and medicine alike

Gavin Yamey has a thought-provoking commentary over at the PLoS blog site, in which he argues that open access to the scientific literature is related to access to essential medicines. One of the points that I agree with is that our system - indeed, even the very notion - of intellectual property rights is preventing both the dissemination of knowledge and of valuable medical treatments.

We scientists publish our work primarily so that it will be disseminated as widely as possible. (Yes, I know that we also publish so that we can get promoted in our jobs, increase our funding, and other less noble goals.) To that end, open access publishing, which puts no barriers in the way of the interested reader, is the best system from the consumer's (reader's) point of view. Even more important, in many cases, is that open access publishing allows the author to retain control of the intellectual property in the article, which is logical enough since the author created it in the first place. It never made sense to me to sign over copyright to a publisher, but publisher's were able to extort these rights from authors when they controlled the means of distribution.

As Yamey points out, access to drugs is restricted in a different - but closely related - way, through patents. I've made arguments against patents before - particularly against patents on software, which I've argued should be abolished (see my editorial here). Drug patents, despite the arguments made by the pharmaceutical industry which has a huge vested interest in the current system, are "impeding the world's poor from accessing live-saving medications," says Yamey. He's right - and more than that, they encourage drugmakers to invest only in blockbuster drugs - not necessarily drugs that cure mankind's greatest ills, but those that make the most profit - and then to invest even more in legal strategies to extend their patents and prevent competition.

Where do our universities sit in this argument? Sadly, in the U.S. at least, universities have been filing 1000's of patents a year. Starting in 1980, when Congress passed a law (the Bayh-Dole Act) encouraging universities to commercialize their discoveries, the growth in university-driven efforts to protect intellectual property has been enormous. On the whole, I believe these efforts have been harmful, because they directly contradict the mission of universities - and scientists - to disseminate knowledge.

Fortunately, there is now a group, Universities Allied for Essential Medicine, that is at least making an effort to pressure some universities to recognize the harm they're doing, and to stop it. They've called on the Univ. of Wisconsin, which has an unusually aggressive licensing arm (called WARF), to demand that Abbott reintroduce a drug that they have withdrawn from Thailand over patent disputes. (WARF owns rights to the drug.) The University of British Columbia has actually drafted a new IP policy that will guarantee access to UBC inventions in the developing world (read it here).

For now, US universities are followers, not leaders. I encourage anyone in academia to pressure your administration at every opportunity to encourage free dissemination of knowledge, through open access and through rapid, unrestricted publication of discoveries - without patents. I'm trying this already at my own institute, the University of Maryland. Not surprisingly I'm meeting resistance, but I will persist, and I hope others will join me.

One thing we professors can do on our own is to halt the practice - common in some disciplines - of counting patents as publications. I've seen many resumes with patents listed, and I don't consider these to be equivalent to publications at all. For one thing, patents aren't peer-reviewed, but are reviewed by an overburdened patent office that lacks expertise in most disciplines. For another, patents are often written to conceal the true invention, so as to discourage others from trying to re-create it. Let your colleagues know that patents don't count in promotion cases, and they'll have less incentive to file them. This is just a small step, but I think it's be a step in right direction.

3 comments:

As always, some good ideas in your article. Where you fall a bit short in your argumentation (and my comment might entice you to have a post on it in the future) is on drug patents. How do you get the safest and most effective drugs on the market. Without resorting to a completely government run process (I doubt it would ever work!) how do you ensure that competing industries can create value (i.e. make profit) from a novel drug, which then allows them to do 10 years of more research and clinicl development for the next drug. This is not just a rhetoric question, but I am looking for real doable solutions. I too believe that the current system is not optimal.

Your post is a little misguided, because it conflates two related but different aspects of scientific research and the fruits of that research.

First, patenting does nothing to reduce the dissemination of scientific information, which you rightly identify as the basis for university research. One example will suffice: if I clone a nucleic acid encoding a gene, any patent application I file (usually) must disclose the nucleotide sequence of the gene (as well as providing information on the protein it encodes and the function of that protein). Once that information is made public (and once I have filed I can post it on PLoS, for example), the information is in the public domain. Anyone can use it, to interrogate a database or compare it with other sequences, even new ones they may have discovered. That's because you cannot patent information per se, only physical embodiments such as the nucleic acid itself (which the law treats as a chemical, albeit a complex one).

On the other hand, the patent gives the owner the right, for a limited time (20 years from the filing date of the application), to prevent others from using the invention. Whether you believe it or not, having patent protection is essential for companies, particularly small companies, to get the investment needed to go from the lab bench to the market. And universities benefit because they can license the technology and reap economic benefits of the research, which can be used to build new labs, support graduate students, etc.

The alternative is for the information produced by American universities to be used by industry free of charge, since university professors need to disseminate the information to fulfill their purpose as members of the scientific community, and (as you posted) get jobs and tenure and grants and all the rest. So there is certainly a need for a way that the scientific community can provide the freest flow of information while at the same time protecting those inventions that are economically valuable. That way is patenting.

I am unqualified to opine on whether software patents are good or bad - every piece of software I've ever used has had a license agreement attached to it, and if I didn't agree I couldn't use the software. Since copyright lasts much longer than patenting, I think we are better off having patents cover software, since if that was the only protection available Microsoft would be losing patent rights over Word etc. by now.

But I think you do the university community a disservice by railing against a system that has provided them with a modicum of independence from the vagaries of the political winds from Washington (the only other source of funding, at least in the biological sciences). Without industry sources of funding, which rely on the right to patent, President Bush's stem cell ban would have shut down ALL stem cell work in the US over the past 6 years, since the limited number of cell lines falling outside the ban are well recognized as being inadequate for research purposes.

Finally, the activities of Western pharmaceutical companies in places like Thailand are part of a very complex dance between the developing world and the West that has been playing out over the past dozen years. Without some global agreement, countries like Thailand will have no difficulty obtaining generic versions of the drugs Western countries have developed, since the international agreements many thought would protect patent holders have in fact been turned against them, and there is effectively no way to stop Thailand and other countries from importing generic drugs from China, India and elsewhere.

Even for those who support efforts to ensure essential medicines are available to people in the developing world (and I count myself among them), the economic facts are that investment-intensive businesses like pharma that lose market share to competitors get into trouble; like it or not the monies required to bring new drugs to market have to come from the monies made on existing drugs. If that source of funding dries up, or if investors decide that small startup biotechs aren't worth the investment, where will tomorrow's drugs come from?

David:Your argument seems to be that the current system works, so let's leave it alone. You are assuming that useful drugs require 10 years of work to get them to market. This has been true in the past, but we need new ideas and a new process - I think we should be getting drugs to market in months, not years. The patent system helps to perpetuate this frustratingly slow process. Kevin Noonan repeats this point - implicitly - when he writes that patents give inventors "a limited time (20 years) ... to prevent others" from using the invention. True, 20 years is a limit, but it is far too long and it dramatically slows down the pace of innovation.

Kevin:Your arguments sound good, and I've heard them many times before, but I don't buy them. I'll make a couple of quick points: first, about disclosure and dissemination. It's true that patents are supposed to disclose the invention, but patent filers are often very clever about hiding the true intent of the patent. They are being forced - reluctantly - to disclose a discovery, and therefore they don't have an incentive to do a good job of disclosure. Publication in the scientific literature, in contrast, has the opposite purpose, since the whole idea is to describe a discovery. Second, let me quickly throw some cold water on the notion that patents give universities a "modicum of independence" from the politics of government funding, by providing an independent source of revenue. Most people, even those inside academia, aren't aware of the following: (1) virtually all major universities have intellectual property offices, whose goal is to "protect" inventions created by employees (mostly professors and scientific staff). These protections are typically either licenses or patents. But (2) virtually all of the IP offices in the US lose money for their institutions. A recent estimate is that perhaps 2% of such offices yield a profit. (My own institution's internal reports indicate that we're in the unprofitable 98% group.) Thus in all but a few cases, universities would be better off if they stopped spending money trying to wall off its discoveries.